The GI Genius™ system is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.

Device Description

GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.

GI Genius is composed of software (namely, ColonPRO™ 4.0) and hardware (namely, GI Genius™ Module 100 and 200).

GI Genius™ Module 100 and 200 are compatible with Video Processors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) output ports and endoscopic display monitors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) input ports. GI Genius™ Module 200 is also compatible with Video Processors featuring the 4K UHD standard.

The GI Genius system is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function.

During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs.

The operating principle of the subject device is identical to that of the predicate device, this being a computerassisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device includes hardware to support interfacing with video endoscopy systems and the accessories given by the footswitch and the USB K-switch.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the GI Genius™ Module 100, GI Genius™ Module 200, and ColonPRO™ 4.0, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance metric, but it does present a comparison table that shows the performance of the Subject Device (ColonPRO™ 4.0) against its Predicate Device (GI Genius™ System 100 and 200). The implication is that the subject device's performance, being "improved" or "same" compared to the already cleared predicate, meets the necessary equivalence for clearance.

Characteristic	Acceptance Criteria (Implied: at least as good as predicate)	Reported Device Performance (Subject Device - ColonPRO™ 4.0)	Comparison to Predicate (Performance of Predicate)
Lesion-based sensitivity	≥ 86.5%	88.07 %	Improved (86.5 %)
Frame-level True Positive	≥ 269,223	277,738	Improved (269,223)
Frame-level True Negative	For 150 videos/338 polyps: ≥ 5,239,128	5,248,406	Improved (5,239,128)
Frame-level False Positive	For 150 videos/338 polyps: ≤ 104,669	95,391	Improved (104,669)
Frame-level False Negative	For 150 videos/338 polyps: ≤ 192,567	184,052	Improved (192,567)
True positive rate per frame	Mean: ≥ 58.30 %, % of polyps: 100 %	Mean: 60.14 %, % of polyps: 100 %	Improved (Mean: 58.30 %, % of polyps: 100 %)
False positive rate per frame	Mean: ≤ 1.96 %	Mean: 1.79 %	Improved (Mean: 1.96 %)
Frame-Based TPr/FPr ROC curve, AUC	≥ 0.796	0.826	Improved (0.796)
False positive clusters per patient	< 500 ms: ≤ 106, > 500 ms: ≤ 11	< 500 ms: 97, > 500 ms: 10	Improved (< 500 ms: 106, > 500 ms: 11)
Video delay, signal in to signal out	As per predicate (1.52 µs for Module 100, 0.74 µs for Module 200)	1.52 µs (Module 100), 0.74 µs (Module 200)	Same

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly states the frame-level performance was assessed using 150 videos / 338 polyps. It doesn't specify if this refers to the number of patients or individual lesions.
Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It only mentions that "the baseline clinical validation for the subject device was conducted and reviewed in DEN200055 and is still applicable." Since this is a Special 510(k) for a software update (version 4.0.0 replacing 3.0.2), the primary performance data seems to derive from the re-training of the neural network rather than a new clinical study. The "Non-clinical testing" section mentions that "Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K231143 predicate device submission, have been repeated for the applicable parts of the subject device." This suggests the test set for this submission is the same as, or comparable to, that used for the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth on the test set.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or present an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device is described as a "computer-assisted reading tool," suggesting it's intended to work alongside an endoscopist, but no study on human performance improvement with the device is provided in this submission or summary. It refers to the "baseline clinical validation" for the predicate device, but the details of that validation are not present here.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The performance metrics listed in the table (Lesion-based sensitivity, Frame-level True Positive/Negative/False Positive/Negative, True positive rate per frame, False positive rate per frame, Frame-Based TPr/FPr ROC curve, AUC, False positive clusters per patient) all refer to the algorithm's performance without direct human-in-the-loop interaction for the purpose of these specific measurements. The "Non-clinical testing" section explicitly states: "Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K231143 predicate device submission, have been repeated for the applicable parts of the subject device."

7. Type of Ground Truth Used

The document implies the ground truth for polyps and lesions was used to evaluate detection performance. However, it does not explicitly state the method for establishing this ground truth (e.g., expert consensus, pathology, outcome data). Likely, for lesion detection in endoscopic videos, ground truth would typically be established by expert endoscopist review, potentially confirmed by pathology for detected lesions.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only mentions "retraining of the neural network" as the source of improved detection performance for ColonPRO™ 4.0.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established.

Summary

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January 12, 2024

Cosmo Artificial Intelligence - AI Ltd % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 Italy

Re: K233964

Trade/Device Name: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: ONP Dated: December 15, 2023 Received: December 15, 2023

Dear Roger Gray:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233964

Device Name

GI Genius™ Module 100 (GGM100.US): GI Genius™ Module 200 (GGM200.US): ColonPRO™ 4.0 (CPRO40.US)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510(k) Reference:	K233964
Device Name:	GI Genius™ Module 100;GI Genius™ Module 200;ColonPRO™ 4.0.
Type of 510(k) submission:	Special
Date of submission:	15 December 2023
510(k) Owner and Submitter:	Cosmo Artificial Intelligence - Al LtdRiverside II, Sir John Rogerson's QuayDublin D02 KV60Ireland
FDA Establishment Reg. Number:	3018899987
Specification Developer:	Linkverse Srlvia Ostiense 131/L00154 Rome, Italy
Owner/Operator Reg. Number:	3018901422
510(k) Application Correspondent:	Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 Rome, Italy
Phone:	+39 06 578 2665
Email:	rgray@donawa.com
FDA Product Code:	QNP
FDA Regulation Number:	21 CFR 876.1520
FDA Classification Name:	Gastrointestinal lesion software detection system
Classification Panel:	Gastroenterology and Urology
FDA Classification:	Class II

Indications for Use:

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Genius™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.

The indications for use statement is the same as that of the original unmodified (predicate) device, as cleared under K231143.

Device Description:

GI Genius is composed of software (namely, ColonPRO™ 4.0) and hardware (namely, GI Genius™ Module 100 and 200).

The baseline clinical validation for the subject device was conducted and reviewed in DEN200055 and is still applicable to the versions of the device that are the subject of this submission.

Design changes:

This Special 510(k) submission describes the design changes incorporated into GI Genius following FDA clearance under K231143. The device software version number as cleared under K231143 was 3.0.2; the device software version that is the subject of this Special 510(k) is 4.0.0 and it is named ColonPRO™ 4.0.

Two types of design change are detailed in this submission. The first covers the planned design changes that fall within the FDA guideline for submittal of a new 510(k), and the second covers the addition of a new software function with no medical purpose that is included given that it has been developed in the same new version of the software. In addition, a labeling change is planned, to include the non-clinical performance data of the new software version and the instructions to visualize the output readings of the software new other function named Procedure Highlights.

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The technical specifications are identical between the predicate and the subject devices except for the following software change:

New software version ColonPRO™ 4.0 has improved detection performance resulting from the retraining 1. of the neural network. This is the only software change affecting the detection performance.
1. Software items have been updated, without effect on device performance:
- SOUP Ubuntu ver. 20.04 LTS, .
- . SOUP CUDA ver. 11.6,
- . SOUP VideoMasterSDK ver. 6.21,
- . SOUP cuDNN ver. 8.4.1.50,
- SOUP TensorRT ver. 8.4.3.1,
- SOUP VPN and SSH service configured with certification-based authentication,
- SOUP WebKit ver. 2.38.6 for management of interface content,
- Internal wrapper library to VideoGenius library for communication with video card,
- GUI Genius for management of common user interface,
- License Manager for management of software licenses,
- Docker Manager for management of containers.
ColonPRO™ 4.0 has been containerized within the operating system to optimize future deployment of 3. software changes and updates by reorganizing the architecture of the software items. This change does not affect the device performance.
1. ColonPRO™ 4.0 introduces the new non-clinical function Procedure Highlights that provides data to be aggregated and used by healthcare organizations, thus supporting their internal programs on optimization of practices. This other software function is independent with respect to the software detection performance.

Non-clinical testing:

The following non-clinical verification/ validation activities have been completed:

Verification of the revised software at the system level. Each element of the SRS was tested and found to meet specified requirements, testing 33 Units and 22 Items, encompassing 162 software requirements.
Validation of the revised software at the user level has been carried out, incorporating tests sufficient for the validation of the SRS.
. Risk mitigation measures identified during Risk Management have been successfully verified or validated, as applicable.
. Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K231143 predicate device submission, have been repeated for the applicable parts of the subject device.

The results of the above testing aid demonstration of substantial equivalence of the subject device with the predicate device, as the same test protocols have been used where applicable.

Substantial equivalence:

The predicate device for the subject device is the pre-modification version of the same device, Gl Genius, FDA-cleared under K231143 on 19 May 2023:

Predicate Device:	GI Genius™ System 100 and GI Genius™ System 200
Sponsor:	Cosmo Artificial Intelligence - Al Ltd
De Novo Number:	K231143
Clearance Date:	19 May 2023
FDA Product Code:	QNP
Classification Name:	Gastrointestinal lesion software detection system
Regulation No:	21 CFR 876.1520
Class:	II

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Predicate device comparison table:

Table 1 provides evidence of substantial equivalence of the subject device with the predicate device.

Characteristic	Subject device		Predicate device		Comparison
Device name	GI Genius™Module 100 withColonPRO™ 4.0	GI Genius™Module 200 withColonPRO™ 4.0	GI Genius™System 100	GI Genius™System 200	Differentdevice name
Manufacturer	Linkverse S.r.l., Italy		Linkverse S.r.l., Italy		Same
FDA clearance	This submission		K231143		N/A
FDA Reg name	Gastrointestinal lesion softwaredetection system		Gastrointestinal lesion softwaredetection system		Same
FDA Reg #	21 CFR 876.1520		21 CFR 876.1520		Same
FDA Product Code	QNP		QNP		Same
Indications for Use	The GI Genius™ system is a computer-assisted reading tool designed to aidendoscopists in detecting colonicmucosal lesions (such as polyps andadenomas) in real time during standardwhite-light endoscopy examinations ofpatients undergoing screening andsurveillance endoscopic mucosalevaluations. The GI Genius™ computer-assisted detection device is limited foruse with standard white-light endoscopyimaging only. This device is not intendedto replace clinical decision making.		The GI Genius System is a computer-assisted reading tool designed to aidendoscopists in detecting colonicmucosal lesions (such as polyps andadenomas) in real time during standardwhite-light endoscopy examinations ofpatients undergoing screening andsurveillance endoscopic mucosalevaluations. The GI Genius computer-assisted detection device is limited foruse with standard white-light endoscopyimaging only. This device is not intendedto replace clinical decision making.		Same
Video delay, signal into signal out	1.52 µs	0.74 µs	1.52 µs	0.74 µs	Same
Lesion-basedsensitivity	88.07%		86.5 %		Improved
Frame levelperformance(150 videos / 338polyps)	True positive: 277,738True negative: 5,248,406False positive: 95,391False negative: 184,052		True positive: 269,223True negative: 5,239,128False positive: 104,669False negative: 192,567		Improved
True positive rate perframe	Mean: 60.14 %% of polyps: 100 %		Mean: 58.30 %% of polyps: 100 %		Improved
False positive rate perframe	Mean: 1.79%		Mean: 1.96 %		Improved
Frame-Based TPr/FPrROC curve, AOC	0.826		0.796		Improved
False positive clustersper patient	< 500 ms: 97> 500 ms: 10		< 500 ms: 106> 500 ms: 11		Improved
Additional videoprocessor	None		N/A		Same
Accessories (optional)	FootswitchUSB K-switch		FootswitchUSB K-switch		Same
Software otherfunction	Procedure Highlights function		None		ProcedureHighlights is anew softwarefunction forinternalprograms ofhealthcareorganizationsonly.
Electrical safety	IEC/EN 60601-1		IEC/EN 60601-1		Same
Electromagneticcompatibility	IEC/EN 60601-1-2		IEC/EN 60601-1-2		Same

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Table 1: Predicate device comparison table
Characteristic	Subject device	Predicate device	Comparison
LAN port	Yes, non-functional to user	Yes, non-functional to user	Same

Conclusion

The subject and predicate devices have identical indications for use and fundamental technological characteristics. Any differences in performance between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device, which is already in interstate commerce within the USA. Therefore, the subject device is as safe, as effective, and performs better than the predicate device.

Regulation Number and Section

§ 876.1520 Gastrointestinal lesion software detection system.

(a)
Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
(i) Standalone algorithm performance testing;
(ii) Pixel-level comparison of degradation of image quality due to the device;
(iii) Assessment of video delay due to marker annotation; and
(iv) Assessment of real-time endoscopic video delay due to the device.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device.
(5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline.
(6) Labeling must include:
(i) Instructions for use, including a detailed description of the device and compatibility information;
(ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making;
(iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and
(iv) A summary of the standalone performance testing and associated statistical analysis.